Capillary electrophoretic assay for the stability of tris(8-quinolinolato)gallium(III) in tablet formulations.

A capillary electrophoresis (CE) method for testing the stability of a novel oral anticancer metallodrug, tris(8-quinolinolato)gallium(III) (KP46), is proposed. As both the intact drug and its eventual impurity or/and decomposition product, 8-quinolinol, are not charged (at most of the pH range), the micellar-mediated CE mode based on using micellar concentrations of sodium dodecyl sulfate was employed. The running electrolyte conditions were optimized in order to resolve the peak of KP46 from the signal of 8-quinolinol, as well as from these of tablet matrix components. The stability of KP46 in different organic and water-organic solvent systems was studied regarding its limited solubility and the following recovering experiments. The method thus developed was applied to the determination of KP46 in tablet formulations, for which sample preparation method, namely powdering and ultrasound-assisted extraction (with 50% aqueous acetone), was tested and optimized in terms of procedure time (10 min). Different in the content of the active substance (10-30%) batches of tablets stored for two years after preparation were validated and recoveries obtained at the level from 97 to 102% confirmed sufficient drug stability. This principal finding was verified by means of an independent method, gas chromatography coupled with mass spectrometry (GC-MS).